Sentences with phrase «on the clinical trial report»

The two drug combination «reveals the possibilities of combining an immune signaling molecule with taking the brakes off at the same time,» said F. Stephen Hodi, MD, first author on the clinical trial report.

Not exact matches

Following a devastating clinical trial setback earlier this month for its lead experimental product, a cannabidiol gel, in epilepsy, the firm reported another trial failure on Monday for the product in treating knee pain due to osteoarthritis.

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

And the San Francisco Chronicle reports that over 100 clinical trials listed on the ClinicalTrials.gov website feature Fitbit trackers in addition to those trials using the Apple Watch, Jawbone, Garmin, Pebble and other devices.

A March 28, 2018, research note by JMP Securities analyst Michael King indicated that at the recent International Symposium on Amyloidosis in Japan, Alnylam Pharmaceuticals Inc. (ALNY: NASDAQ) reported multiple sets of results of clinical trials, separately evaluating its investigational RNA interference (RNAi) therapeutics patisiran and ALN - TTRsc02.

More details on a pivotal clinical trial mixed with a bullish analyst report send shares screamin...

Although some SIDS experts and policy - makers endorse pacifier use recommendations that are similar to those of the AAP, 272,273 concerns about possible deleterious effects of pacifier use have prevented others from making a recommendation for pacifier use as a risk reduction strategy.274 Although several observational studies275, — , 277 have found a correlation between pacifiers and reduced breastfeeding duration, the results of well - designed randomized clinical trials indicated that pacifiers do not seem to cause shortened breastfeeding duration for term and preterm infants.278, 279 The authors of 1 study reported a small deleterious effect of early pacifier introduction (2 — 5 days after birth) on exclusive breastfeeding at 1 month of age and on overall breastfeeding duration (defined as any breastfeeding), but early pacifier use did not adversely affect exclusive breastfeeding duration.

While anecdotal and clinical experience supports improvement in milk production for women with insulin resistance who start or resume metformin, Vanky and colleagues (Vanky, Nordskar, Leithe, Hjorth - Hansen, Martinussen, & Carlsen, 2012) reported after a randomized, controlled trial that metformin had no effect on breast changes / size increase in pregnancy or breastfeeding in women who were obese.

Based on results of the current study described in a report online June 18 in the journal Cancer Cell, Johns Hopkins researchers say they are planning a phase I clinical trial to test the paclitaxel - fostamatinib combination therapy in patients with recurrent advanced ovarian cancer.

A damning report on how the University of Minnesota (UM) protects volunteers in its clinical trials concludes that researchers inadequately reviewed research studies across the university and need more training to better protect the most vulnerable subjects.

As Scientific American reported earlier this year, more than half of the current cancer clinical trials do incorporate some form of immunotherapy but still oncologists are often only in the early stages of understanding how to use such treatment on a larger scale.

All groups of both species showed improvement over the course of 10 to 12 trials, but the healthy participants consistently reached the target with a more economic route, the team reports on today in the Journal of Clinical Investigation.

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

The study can be seen in Cell Reports and provides an explanation for why the clinical trials for Alzheimer's disease drugs have failed and gives new light on the discord between preclinical and clinical findings.

«Millions of volunteers have participated in clinical trials to help find out more about the effects of treatments on disease, yet the important ethical issue of reporting results has been ignored widely.

► «A damning report on how the University of Minnesota (UM) protects volunteers in its clinical trials concludes that researchers inadequately reviewed research studies across the university and need more training to better protect the most vulnerable subjects,» Jennifer Couzin - Frankel wrote Monday at ScienceInsider.

The Institute of Medicine (IOM) report says that so - called «omics» tests — diagnostic tools based on molecular patterns — are highly prone to errors; it recommends they be rigorously validated before being used in clinical trials.

Today, The New York Times reports that on Sunday Duke decided to halt enrollment in three clinical trials in which Potti and Duke's Joseph Nevins were using gene - expression signatures to predict a patient's response to chemotherapy.

The study is investigator led and has therefore focused on clinical need, targeting patients with progressive multiple sclerosis in whom most disability is incurred... The study also reports a predominant effect on neurodegenerative rather than inflammatory outcomes, suggesting a novel mechanism of action that might be suitable as combination treatment with immunomodulatory treatments... Further phase 3 studies to measure the effect of simvastatin on sustained disability, particularly in patients with non-relapsing secondary progressive and primary progressive multiple sclerosis, are clearly needed, but this trial represents a promising point from which to develop trials of progressive disease.»

Results of the first 12 women enrolled at Johns Hopkins on a clinical trial led by Trimble are reported online in the Jan. 27 issue of Science Translational Medicine.

One report, focusing on clinical trial patients with advanced kidney cancer treated with checkpoint inhibitors, is from scientists at Dana - Farber Cancer Institute and the Broad Institute of MIT and Harvard, led by Eliezer Van Allen, MD, of Dana - Farber and the Broad, and Toni Choueiri, MD, director of the Lank Center for Genitourinary Oncology at Dana - Farber.

Their report set intake levels based only on clinical trial data.

Topamax, an epilepsy drug from Ortho - McNeil Pharmaceutical, has proven extremely effective on migraines in clinical trials: Half of all patients have reported a 50 percent reduction in the frequency of migraines, and more than a quarter have a reported 75 percent reduction.

But in the mid-1980s a series of negative reports based on better - controlled clinical trials concluded that piracetam was ineffective.

The report from an international committee convened by the U.S. National Academy of Sciences (NAS) and the National Academy of Medicine in Washington, D.C., concludes that such a clinical trial «might be permitted, but only following much more research» on risks and benefits, and «only for compelling reasons and under strict oversight.»

The ICMJE, whose membership includes the editors of The Journal of the American Medical Association (JAMA), The Lancet and the New England Medical Journal, announced the proposal one year after a report by the Institute of Medicine called on stakeholders to address the key challenges associated with sharing clinical trial data so as to «foster a culture in which data sharing is the expected norm» [2].

The scientists report online in Nature on June 14 that their bioengineered human liver tissues still need additional rounds of molecular fine tuning before they can be tested in clinical trials.

Piller and Bronshtein's work, and the follow - up pieces that came out of this investigation, applied real pressure on the government to fortify its efforts to improve clinical trial data reporting.

News and reports of the latest clinical trials, translational medicine, drug development and research with potential for direct impact on human health.

CVC researchers, including Elke Jaeger, Julia Karbach, Danila Valmori, Maha Ayyoub, Gerd Ritter, Dirk Jaeger, Eric Hoffman, Linda Pan, Lloyd J. Old, and Alex Knuth report on the first clinical trial with virus - encoded NY - ESO - 1 in a prime - boost setting.

These risks and uncertainties include, among others, those relating to our ability to obtain financing and to form collaborative relationships, uncertainty regarding potential future deterioration in the market for auction rate securities which could result in additional permanent impairment charges, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.

First, some background: Based on recommendations outlined in the 2010 National Advisory Mental Health Council (NAMHC) report, «From Discovery to Cure,» and the need for cost - effective development of novel interventions, NIMH has shifted away from a traditional approach to clinical trials.

Combining Viral Vectored and Protein - in - adjuvant Vaccines Against the Blood - stage Malaria Antigen AMA1: Report on a Phase 1a Clinical Trial.

A new paper published in the Journal of Allergy and Clinical Immunology has reported on a multicentre trial to test the safety and clinical efficacy of a new vaccine against grass pollen allergy in patients with grass pollen — induced rhinitis and controlledClinical Immunology has reported on a multicentre trial to test the safety and clinical efficacy of a new vaccine against grass pollen allergy in patients with grass pollen — induced rhinitis and controlledclinical efficacy of a new vaccine against grass pollen allergy in patients with grass pollen — induced rhinitis and controlled asthma.

Towards the clinical translation of intra-articular injection of MSCs, the group of Kang Sup Yoon at the Seoul National University College of Medicine, Seoul, Korea report on their a proof - of concept phase I / II clinical trial intra-articular injection of autologous adipose tissue derived mesenchymal stem cells (AD MSCs)[6].

Despite 25 years of intense research and thousands of clinical trials of promising new cancer therapies, there has been only scattered progress in treatment since President Richard Nixon declared the «War on Cancer» in December 1971, report two researchers from the University of Chicago in a Special Article in the May 29, 1997 issue of the New England Journal of Medicine.

These risks and uncertainties include, among others, those relating to our ability to obtain sufficient financing to continue as a going concern, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, our ability to form collaborative relationships, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.

May 29, 1997 News from the cancer front: glass remains half empty Despite 25 years of intense research and thousands of clinical trials of promising new cancer therapies, there has been only scattered progress in treatment since President Richard Nixon declared the «War on Cancer» in December 1971, report two researchers from the University of Chicago in a Special Article in the May 29, 1997, issue of the New England Journal of Medicine.

After an exciting day of science yesterday, day 2 saw updates on strategies to rid cells of the harmful mutant huntingtin protein and exciting reports on current and planned clinical trials.

In a substudy, review outcomes were also compared across different types of clinical research, based in large part on the designations and definitions derived from a number of sources, including a report by Nathan, 14 the Institute of Medicine, 20 the NIH Director's Panel on Clinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanclinical research, based in large part on the designations and definitions derived from a number of sources, including a report by Nathan, 14 the Institute of Medicine, 20 the NIH Director's Panel on Clinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanClinical Research, 9 the Association of American Medical Colleges and American Medical Association, 21 and the Agency for Healthcare Research and Quality.22 All 3599 R01 applications involving human subjects that were submitted to NIH for the October 2002 council were categorized into 1 of the following: (1) patient - oriented studies of mechanisms of human disease (bench to bedside); (2) clinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanclinical trials and other clinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified humanclinical interventions; (3) patient - oriented research focusing on development of new technologies; (4) epidemiological studies; (5) behavioral studies (including studies of normal human behavior); (6) health services research; and (7) use of deidentified human tissue.

These risks and uncertainties include, among others, those relating to our ability to obtain sufficient financing to continue as a going concern, the outcome of the review of the continued listing of our common stock on The Nasdaq Stock Market, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, our ability to form collaborative relationships, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.

PPMD and Action Duchenne hosted a webinar update last week on the recent report that Summit has announced positive 24 - week interim results from the open - label Phase 2 proof of concept clinical trial, PhaseOut DMD.

«Previous randomised controlled clinical trials conducted on ear acupressure in the management of hayfever reported it as being effective and safe for hay fever symptom relief,» she says.

Dr. Crofford had been pressing for clinical trials to be done on the drug ever since her days at the University of Michigan in the»90s when she and her colleagues noted anecdotal reports that an older version of the drug seemed to provide their patients some relief.

27 Studies cited by the 2010 DGAC Report demonstrate varied metabolic responses to lowered dietary saturated fat, with certain subpopulations exhibiting adverse rather than improved health outcomes.3 Two recent comprehensive meta - analyses indicate that saturated fat is not linked to heart disease.28, 29 In fact, in a definitive review of forty - eight clinical trials, with over sixty - five thousand participants, the reduction or modification of dietary fat had no effect on mortality, cardiovascular mortality, heart attacks, stroke, cancer, or diabetes.30 Yet, avoiding saturated fat remains a cornerstone of national dietary guidance.

They publish full - length regular articles reporting the results of clinical trials or other experimental procedures, as well as short communications on minor advances in the field and reviews covering topics of special interest.

For a report published in the European Journal of Preventative Cardiology in 2015, researchers analyzed previously published clinical trials on mind - body practices, including meditation.

It concluded four of the randomized clinical trials «did not allow conclusions to be drawn on the effects of isolated soy protein on blood cholesterol concentrations owing to inadequate methodology or insufficient reporting.»